recalls mitigating the risk and managing the process
TRANSCRIPT
RECALLSMitigating the Risk and Managing the Process
Presenter: Susan DeRagon | Date: April 15, 2021
Agenda
Mitigating the Risk
Hazard Identification
Risk Management
Product Life Cycle
Compliance Programs
Managing the Process
Reporting Requirements
Recall Preparedness
Q & A Session
Identify Potential Hazards and Risks
Human Factors Review - Goes Beyond the Standards
Try To Anticipate Foreseeable Use & Unintended Use Scenarios
Understand & Enhance Interaction Between Users & Products
Perform behavioral task analysis
Identify steps associated with product use
Assembly
Intended use
Foreseeable unintended use (misuse)
Cleaning
Troubleshooting
Disassembly
Storage
Hazard identification – external resources
Global regulations
Industry standards – mandatory and voluntary
Are voluntary standards truly voluntary?
CPSC & International Recalls
Incident / injury data, including NEISS data
Anthropometric data – childata, adultdata, older adultdata, strength data for design safety
Hazard identification - internal resources
Customer service feedback
Provide toll-free phone number
Complaints and associated follow-up
Returns/replacement parts/repairs
On-line product reviews / social media
Feedback safety-related issues to product designers and engineers
Central repository for incident reports and other customer feedback
Use standardized checklist
ISO Guide 50, ISO Guide 51
EU Guidelines for Non-food Consumer Products
Hazards – Based on ISO Guide 60 Is the hazard present Has the hazard been addressed
MECHANICAL HAZARD
Gaps and openings
Protrusions
Corners, edges and points
Projectiles
Hazards for small objects
Non-permeable enclosures
Inadequate stability
Inadequate structural integrity
Hazardous heights
Moving and rotating objects
Noise
Drawing hazards
Internal Hazard Pattern Checklist
ISO 13077
FMEA can quantify risks
Process of systematically identifying hazards to determine outcome and level of risk
EU Guidelines for Non-Food Consumer Products
Design Hazard Out
Likelihood of hazard occurring
Severity of potential injury
Technologically feasible
Financially feasible
High risk or high profile category
Guard Against The Hazard
Physical Guard
Procedural Guard
Proper Manufacturing Controls
Select suitable vendor/factory
Review factory flowchart and quality control (QC) plan
• Critical processes
• In-factory testing
Start-up and In-process Monitoring
Store / Merchandising
Transportation
Product Concept
Quality & Capability Audit
Social Audit
Raw Materials Testing /Testing to Failure
In-Line / In-Process Inspection
ProcessAudits
Pre-Shipment Inspection
DistributionReturn to Vendor Analysis
C-TPAT / Security Audit
Vendor Selection
Pre-Production
Production
LoadingInspection
GAPAnalysis
Sensory Testing
Concept/Design Review
SupplierQualification
Risk Assessment
Label Evaluation & Verification
Production Monitoring
Raw Materials Traceability
InterventionTesting
Compliance & Performance Testing
Final Random Inspections
CUSTOMERDATA MANAGEMENT
Product Safety throughout the Life Cycle
Product Safety: It’s More Than Regulatory Compliance
Date: March 25, 2021
https://www.qima.com/webinar/2021-
03-product_safety_-_its_more_than_regulatory_compliance
Compliance Programs
Provide employees with written standards/policies, compliance training, and the means to report compliance-related concerns confidentially
Maintain and enforce a system of internal controls and procedures to ensure that the firm promptly, completely, and accurately reports required information about its products to the CPSC
Ensure that information required to be disclosed by the firm to the Commission is recorded, processed, and reported per applicable law
Establish an effective program to ensure the firm remains in compliance
Ensure that prompt disclosure is made to the firm’s management of any significant deficiencies or material weaknesses in the design or operation of such internal controls
Risk Management Program
Test Program vs. Risk Management Program
Process Test Program Risk Management Program
Product design / Packaging evaluation
Photo, Product name plate
Production readiness review
Raw materials / Preproduction testing
Research testing / Testing to failure
On-site validation / In-line factory audit
Finished product testing
Sample selection By Factory By Independent third party
Testing sample size Minimal Statistically valid
Testing frequency Once Statistically valid
Formal corrective action / Preventative action plan
Pre-shipment inspection
CPSC Reporting Requirements
Section 15
Section 37
Section 102
PART OF
Consumer Product Safety Act
PART OF
Child Safety Protection Act
A firm must notify the Commission immediately if a product:
Fails to meet a consumer product safety standard or banning regulation
Contains a defect which could create a substantial hazard to a consumer
Fails to comply with a voluntary standard which the Commission has relied on, under the CPSA
SECTION 15
Reporting Requirements
SECTION 15
How To Report
Firms must file a report with the CPSCOffice of Compliance and Field Operations :
Electronically: SaferProducts.gov
Telephone: 301-504-7520
Fax: 301-504-0359
Email: [email protected]
Mail: 4330 East West Hwy, Bethesda, MD 20814
Description of the product
Name and address of the company (manufacturer, supplier, distributor, importer or retailer)
The possible product defect or unreasonable risk of serious injury or death
Nature and extent of the injury or possible injury associated with the product
Name, address and telephone number of the person informing the Commission
A timetable for providing information not immediately available
SECTION 15
What To Report
SECTION 15
When To Report
Must report “immediately”
Within 24 hours of obtaining the information
CPSC encourages companies to report potential substantial product hazards even while their own investigations are continuing
Firms may investigate the matter for 10 working days
SECTION 15
Evaluation of Report
CPSC will evaluate whether or when a firm should have reported
Evaluation is based on what the company actually knew about the hazard posed by the product or on what a reasonable person should have known about the product hazard
A firm is deemed to know what it would have known had it exercised due care in analyzing reports of injury, consumer complaints, warranty of returns, reports of experts, etc.
SECTION 15
Criteria For Substantial Product Hazard
Pattern of defect
Severity of risk
Number of defective products distributed in commerce
Likelihood of injury
Fast Track Product Recall Program
Firms that file Section 15 reports may wish to use an alternative procedure to expedite recalls
Within 20 working days of filing a potential product defect report, the CPSC can implement a consumer-level voluntary recall
Allows the firm and the Commission to create an immediate corrective action without spending time and other resources to investigate
Fast Track Product Recall Program
Provide all information required for a full report
Request to participate in this program
Submit a proposed corrective action plan with sufficient time for the Commission to analyze any proposed repair, replacement or refund and to evaluate all notice material before implementation of the voluntary recall
A firm must notify the Commission immediately if:
a product is the subject of at least three civil actions filed in federal or state court
each suit alleges the involvement of the product in death or grievous bodily injury
during two-year periods, each of the three actions result in either a final settlement involving the manufacturer in a court judgment in favor of the plaintiff
manufacturer is involved in the defense of or has notice of each action prior to the entry of the final order
SECTION 37
Reporting Requirements
What to report
When and where to report
Confidentiality of reports
SECTION 37
Other Information
Child Safety Protection Act requires companies to report certain choking incidents to the Commission if:
a child, regardless of age, choked on a marble, small ball, balloon or small part;and
as a result of the incident, the child died, suffered serious injury, ceased breathing for any length of time or was treated by a medical professional
SECTION 102
Reporting Requirements
Name and address of the child who choked
Name and address of the person who notified the firm of the incident
Any resulting injuries or medical treatment
Information about any changes made to
the product involved or its warning labels
Details of any public notice or other corrective action planned
SECTION 102
What To Report
Must be filed within 24 hours of obtaining the information
Must be filed with the Office of Compliance and Field Operations
• By Mail
• By Telephone (301-504-7520)
• By Fax (301-504-0359)
SECTION 102
When and Where To Report
Consumer complaints
Warranty returns
Parts replacement
Insurance claims or payments
Product liability lawsuits
Reports of production problems
Product test reports
Design evaluations / risk assessments
SaferProducts.gov
Recall websites
Product Recall Preparedness
What is intended utility of the product?
How is it supposed to be used, how could it be “misused”?
Who is exposed to the product?
What is intended age of the user, the target audience?
Are certain age groups more exposed to potential injuries than others by using the product?
What types of potential injuries can the product cause?
What are patterns of consumer use? Are there similar products that have been recalled?
What changes can be made to eliminate or reduce the potential hazards and risks?
Identify Product Defects
Before any incident or recall, develop a recall plan with your team.
Establish a recall plan and team
Clearly define team roles and responsibilities
Create ready-to-go procedures, templates and scripts
Practice and test all recall procedures
Prepare A Recall Plan
Determine what the defect is and what caused it
Locate unsafe products
Determine if product failed to comply with safety regulations
Verify the defect/non-conformity and severity of productfailure through additional testing
Inform appropriate regulatory bodies
Discontinue product and shipment
Notify distributors to stop selling the product
Prepare a press release announcing recall
Establish toll-free number to handle expected calls
Estimate cost of the recall campaign
Provide reports of the progress of the recall to the Commission
Establish or upgrade quality control procedures to prevent similar recalls
Prepare A Product Recall
Locate all defective product as quicklyas possible
Remove defective products from the distribution chain and from the possession of consumers
Communicate accurate and understandable information in a timely manner to the public about the product defect, the hazard, and the corrective action
Objectives Of A Recall
Joint news release from the CPSC and company
Video news release
Radio announcements
Recall posters
Information on the company websites
Trade associations and newsletter services
Social media sites – YouTube, Facebook, Twitter, Pinterest, Flickr, blogs…
Formal notices to distributors, retailers,sales reps, end buyers
Incentives to return the product
Communicating Recall Information
Name and location of the recalling firm
Name and description of the product
Number of products involved
Description of the hazard
Number of reported deaths, injuries andincidents relating to that hazard
Detailed description of the product includingmodel numbers, colors, sizes and any labelingon the packaging (including tracking labels)
Photo of the product
Where and when the product was distributed to end users
Complete instructions on how to participate in the recall
Recall News Releases
Determine suitable remedy
Ensure replacement is safe and compliant
Deliver your remedy in a timely manner
Document all remedies delivered
Segregate recalled items from non-recalled items that may also be returned by consumers
Establish a product disposition strategy
Managing Remedies
Records of complaints, warranty returns, insurance claims and lawsuits
Production records
Distribution records
Quality control records
Test reports
Certificates of compliance
Tracking label information
Product registration cards
Maintaining Records
Preparation is Essential
Monitor the Market
Reporting Procedures
Roles and Responsibilities of Recall Coordinator and Recall Team Members
Product Recall Manual
1. Product Evaluation
2. Identify Implicated Products
3. CPSC Notification and Recall Agreement
4. Product Removal
Recall Procedures
